Status:
COMPLETED
Immunochemotherapy, in Vivo Purging, PBSC Mobilization and Autotransplant in Relapsed or Refractory Follicular Lymphoma
Lead Sponsor:
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Follicular Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the rate and duration of complete remission and molecular response in patients with relapsed/refractory follicular lymphoma, using a combined treatment with r...
Detailed Description
Autologous stem cell transplantation has been shown effective in the long-term control of follicular lymphoma. Lymphoma, however, can progress after high-dose treatments. Lymphoma cells have been prov...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with relapsed or refractory follicular lymphoma after chemotherapy
- Patients with relapsed or refractory follicular lymphoma after rituximab as single agent or with chemotherapy
- Patients with transformed follicular lymphoma
- CD20-positivity
- Age between 18 and 60 years
- Advanced Ann Arbor stage
- Normal cardiac, renal and hepatic functions
- Negativity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Total amount of anthracycline previously received \< 300 mg/m\^2
- Exclusion criteria:
- Creatinine \> 2 mg/dl
- Alanine transaminase (ALT) and alkaline phosphatase \> 2N
- Cardiac or pulmonary disease
- Severe organic or psychiatric disease
- Positivity for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV)
- Pregnancy, breastfeeding
- Cancer diagnosis in the 5 years before lymphoma diagnosis, except of non-melanoma skin cancer and Cervical Intraepithelial Neoplasia (CIN)
Exclusion
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00366275
Start Date
January 1 2002
End Date
September 1 2007
Last Update
October 31 2012
Active Locations (1)
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1
Division of Hematology, IRCCS Policlinico S. Matteo, University of Pavia
Pavia, Italy, 27100